翻訳と辞書
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・ SITE Design Group
・ Site diversity
・ SITE Engineering College
・ Site Exploitation
・ Site Finder
・ Site Gallery
・ Site historique maritime de la Pointe-au-Père
・ Site index
・ SITE Institute
・ SITE Intelligence Group
・ Site John McCrae
・ Site license
・ Site management organization
・ Site manager
・ Site map
Site Master File
・ Site Multihoming by IPv6 Intermediation
・ Site No. JF00-072
・ Site No. RH00-062
・ Site of Biological Importance
・ Site of California's First Grange Hall
・ Site of Community Importance
・ Site of Ferdinand Branstetter Post No. 1, American Legion
・ Site of Joining Forces in Wenjiashi of Autumn Harvest Uprising
・ Site of Nature Conservation Interest
・ Site of Old Croton Dam
・ Site of Old Hannastown
・ Site of Special Scientific Interest
・ Site of Special Scientific Interest (Hong Kong)
・ Site of the Claudian invasion of Britain


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Site Master File : ウィキペディア英語版
Site Master File

Site Master File or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer.〔(【引用サイトリンク】title=SMF: PIC/S explanatory notes )
==About==
A site master file is a document prepared by the manufacturer containing specific and factual GMP
information about the production and/or control of pharmaceutical manufacturing operations carried
out at the named site and any closely integrated operations at adjacent and nearby buildings. If only
part of a pharmaceutical operation is carried out on the site, the site master file need describe only
those operations, e.g., analysis, packaging.〔(【引用サイトリンク】title=WHO: Guidelines for drafting a Site Master File )

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
ウィキペディアで「Site Master File」の詳細全文を読む



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